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Sharan Murugan
Nov 272 min read
USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
The USFDA continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...
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Sharan Murugan
Oct 172 min read
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024) has issued two comprehensive Q&A guidance titled " Core...
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Sharan Murugan
Apr 272 min read
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
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Sharan Murugan
Nov 6, 20232 min read
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
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Sharan Murugan
Dec 6, 20221 min read
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
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Sharan Murugan
Aug 30, 20211 min read
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
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Sharan Murugan
Aug 8, 20211 min read
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...
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